Lead Quality Systems Specialist

PURPOSE AND SCOPE:

Acts as a subject matter expert to support the organization with initial compliance and ongoing preparation, testing, and monitoring of conformance to established quality systems processes and standards for manufacturing and production.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• A seasoned, experienced professional with full understanding of quality systems; resolves a wide range of issues in creative
• ways.
• Performs high level evaluation of internal controls, communications, risk assessments, and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
• Trains other staff members
• Responsible as back-up for manager when manager is not available Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.
• Facilitates internal training on quality assurance requirements, processes, and procedures.
• May perform audits and risk assessments.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Networks with senior internal and external personnel in own area of expertise.
• Normally receives little instruction on day-to-day work and general instructions on new assignments.
• Acts as a back-up subject matter expert
• Provides assistance to lower-level staff with more complex tasks that require a higher level of understanding of functions.
• Escalates issues to supervisor/manager for resolution, as deemed necessary.
• Mentors other staff as applicable.
• Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state,
• and federal laws and regulations.
• Assists with various projects as assigned by a direct supervisor.
• Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable
• individuals with disabilities to perform the essential functions.
• The individual will, for the most part, be seated and work at a computer and utilize telephone equipment.
• Travel may be required, as necessary.

EDUCATION:

• Bachelor’s Degree required. Advanced Degree preferred or an equivalent combination of education and experience

EXPERIENCE AND REQUIRED SKILLS:

• 6 – 8 years’ related experience or an equivalent combination of education and experience.
• Highly autonomous. Minimal supervision required.
• Self-starter with the ability to work well both independently and as part of a small team.
• Can prioritize tasks accordingly.
• Very detail-oriented, well organized, and driven to meet deadlines and program goals.
• Strong verbal and written communication skills.
• Good computer skills with knowledge of Microsoft Office including Access, email platforms, ERP software, and Microsoft
• Outlook
• Ability to work in a high stress environment given the nature and process.
• Ability to generate moderately complex spreadsheets with graphs for trending data and presentations.
• Knowledge and application of metrics and charts for quality system processes.
• Excellent project prioritization, planning, and management.

ADDENDUM:

Corrections and Removals

• Ensures effective Recall Strategy (includes Customer and internal communications), Recall Tracking, and Recall Termination.
• Responsible for monthly recall status updates to FDA.
• Ensures timeliness of invoice payment submissions on outside vendor services.
• Back-up keynote speaker to PQTF Monthly meetings on C&R Recalls.
• Product Safety Committee participant and back-up host.
• Responsible as back-up for manager when manager is not available
• Supports FADF, HHA, and Field Action Notification (Safety and Alert) creation activities.
• Back- up for witnessing, documenting, and coordinating recalled material destructions with outside vendors and internal departments.
• Utilizes judgement and discretion to determine when a recall is ready for termination.
• Oversees and maintains all field action campaigns in Access Database
• Mentors and trains subordinate employees.
• Maintains consignee lists within Access Database
• Assists with data collection and distribution of FMCNA Field Action Data.
• Responsible for Monthly Recall Tracker meeting with management.
• Ensures timeliness of recall strategies as outlined in approved field action decision.
• Responsible for timeliness of Complaint Related Returned Goods Material (CRM RGA) dispositions.
• Supports all Corporate Quality Holds Department activities including execution, verification and distribution of hold/dispositions.
• Establishes effective relationships with ORA District Recall Coordinators and vendors to ensure robust recall execution.
• Maintains Pre and Post Market Surveillance industry practice understanding through development trainings.

Experience and Required Skills:

• Prior corrections and removals experience required.
• Proficient understanding of USA, Health Canada and Mexico regulations.

The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies.

Annual Rate: $117000.00 - $196000.00

Non-Bonus Eligible Positions: include language below.
Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave.

Bonus Eligible Positions – include language below.
Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance.

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.

Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors